BioNTech
4Q Revenues: €4.3 billion (-23%)
4Q Earnings: €2.3 billion (-28%)
YTD Revenues: €17.3 billion (-9%)
YTD Earnings: €9.3 billion (-8%)
Comments: Results in the quarter and FY reflect lower demand for COVID-19 vaccines. Approximately 2 billion doses of COMIRNATY invoiced in 2022, including approximately 550 million doses of Omicron-adapted bivalent COVID-19 vaccines.
 
BioNTech expanded its oncology pipeline to 20 programs with 24 ongoing clinical trials including five Phase 2 clinical trials.
 
R&D expenses were €509.8 million in the quarter, compared to €271.5 million for the comparative prior year period. For the year R&D expenses were €1.5 billion, compared to €949.2 million for the comparative prior year period. 
 
In November 2022, BioNTech and Pfizer initiated a Phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of BNT162b4, a next-generation COVID-19 vaccine candidate that aims to enhance SARS-CoV-2 T cell responses and potentially broaden protection against upcoming variants and increase durability of protection.
 
In October 2022, BioNTech and Pfizer initiated a Phase 1 open-label, dose-finding clinical trial to evaluate the safety, tolerability, and immunogenicity of a combination of the COVID-19 and influenza mRNA vaccines and COVID-19 with a single injection. In December, BioNTech and Pfizer received Fast Track Designation from the U.S. FDA for the combination vaccine candidate.
 
The company is also working on the following vaccines: herpes simplex virus vaccine HSV-2 Vaccine Program – BNT163, Malaria Vaccine Program – BNT165, and a Shingles Vaccine Program – BNT167 with Pfizer.